Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile

Reason: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.

Code information: UDI-DI (GTIN): 5415067031594, Serial Numbers: 20110016, 20155472, 20155476, 20166304, & 20168050.

Distribution pattern: New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.